First Korean experience with shape-sensing robotic-assisted bronchoscopy integrated with mobile cone-beam CT: Results from the prospective ULSAN-ION study
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Robotic-assisted Bronchoscopy Combined with Multimodal Imaging for Targeted Lung Cryobiopsies
Published on: July 19, 2024
Ganghee Chae1, Chul Park1, Jin Hyoung Kim1
1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, the Republic of Korea.
Introduction:
Shape-sensing robotic-assisted bronchoscopy (ssRAB) integrated with mobile cone-beam CT (mCBCT) has emerged as a promising platform for the diagnosis of peripheral pulmonary nodules (PPNs), with high diagnostic yield and low complication rates. However, no data have been reported in a Korean population. We evaluated the diagnostic yield and safety of ssRAB integrated with mCBCT in a Korean cohort.
Methods:
This prospective, single-center cohort (the ULSAN-ION study) enrolled patients undergoing ssRAB with integrated mCBCT from July 2025 to April 2026 (ClinicalTrials.gov: NCT07057648). Diagnostic yield was assessed using the strict ATS/ACCP definition at the per-nodule and per-patient levels.
Results:
A total of 111 patients with 140 PPNs were enrolled. Median age was 64.0 years (IQR, 55.5-69.5), and 51.4 % were male. Median nodule size was 14.0 mm (IQR, 10.0-19.2), and nodule morphology included solid (57.9 %), part-solid (28.6 %), and pure ground-glass opacity (13.6 %). A CT bronchus sign was absent in 70.7 % of nodules. mCBCT was performed in 88.6 % of nodules, with tool-in-lesion confirmation in 77.9 % and an overall tool-to-lesion rate of 99.1 %. Per-nodule diagnostic yield was 85.0 % (119/140) and per-patient diagnostic yield was 90.1 % (100/111). A malignant diagnosis was established in 75.7 % of patients, most commonly adenocarcinoma, and a specific benign diagnosis in 14.4 %. Pneumothorax occurred in 4.5 % of patients, with chest tube insertion required in 2.7 %. Airway bleeding (Nashville Grade ≥ 2) occurred in 1.8 %, with no Grade ≥ 3 events.
Conclusion:
This first prospective Korean experience demonstrates that ssRAB integrated with mCBCT achieves high diagnostic yield with an acceptable safety profile for PPN diagnosis.
